FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TENS
K Number: K921110
·
Decision Aug 14, 1992
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
9
Review Days
158
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Basic Information
- Device Name
- TENS
- K Number
- K921110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Staodyne, Inc.
- Date Received
- March 9, 1992
- Decision Date
- August 14, 1992
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Staodyne, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952680 | VARAPULSE-2 | Dec 4, 1995 | Substantially Equivalent |
| K941923 | STERILE TREATMENT ELECTRODE | Jun 2, 1995 | Substantially Equivalent |
| K931925 | TPK CUTANEOUS ELECTRODE | Aug 16, 1993 | Substantially Equivalent |
| K926510 | STAODYN EMS+2 | Aug 11, 1993 | Substantially Equivalent |
| K931424 | MAXIMA I | Jun 4, 1993 | Substantially Equivalent |
| K930865 | STAODYN MAXIMA III | May 13, 1993 | Substantially Equivalent |
| K925898 | MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS | Jan 28, 1993 | Substantially Equivalent |
| K921668 | STAODYN TUWAVE | Aug 3, 1992 | Substantially Equivalent |